Optimizing Collaborative Care for Youth With Persistent Post-Concussive Symptoms

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

More than 1 million U.S. youth sustain a concussion each year, and up to 30% report persistent post-concussive symptoms (PPCS) lasting 1 month or more. PPCS can interfere with normal adolescent development, resulting in issues with socioemotional dysfunction and even school failure. However, few evidence based treatments are available for youth with PPCS. The investigators conducted extensive work adapting a collaborative care framework for youth with PPCS, combining concussion-focused cognitive behavioral therapy (cf-CBT), parent skills training (PST) and care management (CM) to create a wraparound treatment for youth with PPCS that can be delivered either in-person or virtually. They completed an R01-funded randomized controlled trial with this approach, finding effectiveness for youth with PPCS, with improvements in concussive symptoms and quality of life at one year, and 60% of participants completing the intervention entirely virtually. Of note, this intervention is unique in that two of the components are focused on parents or parents and youth together (PST, CM), and only one of the components (cf-CBT) is solely youth focused. The investigators now propose to optimize and refine this approach, conducting a high efficiency MOST (multiphase optimization strategy) trial to assess the contribution of each of the three components (cf-CBT, PST and CM) to effectiveness, thereby enabling streamlining of the intervention to only include active components. The analysis will be factorial, with three intervention components and two levels of each (present or absent), resulting in 8 treatment pathways. The benefit of the MOST approach is that it combines all youth who receive a component, allowing assessment of all treatment components with only a modest sample size. The study will recruit 374 youth with PPCS, randomizing them to one of 8 treatment groups. Youth and/or parents will attend treatment sessions via video conferencing software over three months, and complete surveys regarding primary outcomes (concussive symptoms and health-related quality of life) and secondary outcomes (sleep, pain, mood and parental distress) at 6 weeks, and 3, 6 and 12 months. Potential mediators and moderators will also be assessed to allow for future tailoring and refinement. At the completion of this study, the investigators will have generated a completely optimized and refined intervention for youth with PPCS ready for large scale implementation and dissemination.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 11
Maximum Age: 18
Healthy Volunteers: f
View:

• 11-18 years old

• Health care provider diagnosed concussion within 1-12 months

• ≥ 3 new onset or worsening post-concussive symptoms (measured with the HBI)

• Can be located anywhere as study is all completed remotely

Locations
United States
Texas
University of Texas Southwestern (UTSW)
RECRUITING
Dallas
Contact Information
Primary
Sara P Chrisman, MD MPH
chip@seattlechildrens.org
(206) 987-2028
Backup
Carolyn McCarty, PhD
Time Frame
Start Date: 2023-11-10
Estimated Completion Date: 2028-01-31
Participants
Target number of participants: 304
Treatments
Experimental: Pathway 1
All interventions: cf-CBT, PST \& CM
Experimental: Pathway 2
cf-CBT \& PST
Experimental: Pathway 3
cf-CBT \& CM
Experimental: Pathway 4
cf-CBT only
Experimental: Pathway 5
PST \& CM
Experimental: Pathway 6
PST only
Experimental: Pathway 7
CM only
No_intervention: Pathway 8
No interventions
Related Therapeutic Areas
Sponsors
Collaborators: University of Washington, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Texas Southwestern Medical Center
Leads: Seattle Children's Hospital

This content was sourced from clinicaltrials.gov